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Trial record 4 of 7 for:    "Esophageal Disease" | "Methylprednisolone"

Effect of Local Intraoperative Steroid on Dysphagia After ACDF

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ClinicalTrials.gov Identifier: NCT03311425
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kern Singh, Rush University Medical Center

Brief Summary:
The purpose of this study is to determine if the incidence and duration of postoperative dysphagia are improved in the participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone.

Condition or disease Intervention/treatment Phase
Dysphagia Drug: Methylprednisolone Drug: Dexamethasone Phase 3

Detailed Description:
Postoperative dysphagia is a known complication of anterior cervical spinal fusion (ACF) surgery with a published incidence that ranges from 1.7% to 50.3%.1-9 The pathophysiology of post-operative dysphagia is not fully understood and is subject to further study. Postoperative dysphagia has been reported to improve with time with a mean incidence of 19.8% at 6 months, 16.8% at 12 months, and 12.9% at 24 months after ACDF. The investigator's standard of practice is to provide 10mg of dexamethasone IV intraoperatively in order to reduce postoperative prevertebral soft tissue swelling. Despite the growing popularity of ACDF procedures, there is a lack of clear evidence supporting the utilization of perioperative corticosteroids in the setting of an ACDF.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : June 27, 2017
Estimated Study Completion Date : September 13, 2020


Arm Intervention/treatment
Active Comparator: Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Drug: Methylprednisolone
Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure

Drug: Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively

Placebo Comparator: IV dexamethasone
Intraoperative systemic (IV) steroid (dexamethasone) only.
Drug: Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively




Primary Outcome Measures :
  1. Change from baseline SWAL-QOL survey at 3 months [ Time Frame: 3 months ]
    In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit. This will be compared to preoperative scores. Each survey is scored out of 100 with minimum score of 20 indicating severe dysphagia and 100 indicating no dysphagia/normal swallowing. As such, a greater decrease in SWAL-QOL score from preoperative (baseline) to 3 month visit indicates greater postoperative swallowing difficulty.


Secondary Outcome Measures :
  1. Change from Baseline Prevertebral Soft Tissue Swelling at 3 months [ Time Frame: 3 months ]
    Prevertebral soft tissue swelling will be measured utilizing the standard of practice plain lateral radiographs that are obtained at the 3 month postoperative follow up office visit.The area of the prevertebral soft tissue density will be measured from the caudal border of C1 to the cranial end plate of C7 with a digital measuring instrument. These measurements will be compared to the preoperative measurements obtained utilizing the preoperative lateral plain radiographs which are also standard of practice.

  2. Adverse Events [ Time Frame: 1 year ]
    Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing a primary 1- to 3-level ACDF:

    (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

  • Patients able to provide informed consent

Exclusion Criteria:

  • Allergies or other contraindications to medicines in the protocol including:

    (a) Existing history gastrointestinal bleeding

  • Existing history of dysphagia
  • Current Smokers
  • Cervical spine trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311425


Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Kern Singh, MD Rush University Medical Center

Publications:
Lee JY BR, Furey CG, ., et al. Dysphagia after anterior cervical spine surgery: Pathophysiology, incidence, and prevention. Cervical Spine Research Society 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kern Singh, Professor of Orthopaedic Surgery, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03311425     History of Changes
Other Study ID Numbers: 13092002
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kern Singh, Rush University Medical Center:
Anterior cervical discectomy and fusion
prevertebral swelling
swallowing
methylprednisolone
intraoperative steroid
Additional relevant MeSH terms:
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Esophageal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action